Validatable dry steam cleaning for sterile, safe and high-precision production processes
The pharmaceutical industry and medical technology are subject to highest requirements in terms of cleanness, sterility, process reliability and regulatory compliance. Production facilities, cleanrooms, packaging cells, dosing systems, tablet presses, surgical instruments or components for implants must be cleaned in a microbiologically safe, residue-free and validatable manner.
Even minimal product residues, particles or microbiological contamination can: lead to rejection of batches, disrupt validation processes, cause high compliance risks or trigger critical risks for patients.
Manufacturers need a cleaning process that is both technically precise as also regulatory compliant – while also being highly efficient with minimal downtimes and less resource consumption.
Typical challenges:
- Residues of active ingredients, powders, granules, suspensions, gels, oils or emulsions that settle on machinery and surfaces.
- Microbiological contamination in joints, pipe lines, valves, sealing areas and tools.
- Hygiene-critical product contact surfaces in plants for tablet pressing, capsule filling, bottling or assembly.
- Sensitive electronic systems, sensors and actuators that do not tolerate moisture or chemical cleaning agents.
- Strict regulatory requirements (GMP, FDA, EU Annex 1, ISO 13485, ISO 14644), which demand residue-free and validatable cleaning.
- Excessive time and documentation requirements for batch changes, product variants and sterile rooms.
- Chemical-based cleaning processes, which leave residues, entail validation risks and incur high costs.
- Complex geometries in medical device assemblies that are hard to reach manually.
Dry steam cleaning – validatable, sterile, highly effective and ideal for sensitive production environments
Dry steam technology offers significant advantages in the pharmaceutical and medical technology sectors – both from a technical and a regulatory perspective.
Advantages:
- Validatable, residue-free cleaning
No chemical residues
Ideal for supporting GMP and FDA requirements
Reproducible results for audits and documentation - Hygienically safe germ reduction
Superheated steam reduces germs, biofilms, bacteria, yeast and mould
Particularly suitable for cleanrooms, sterile areas and aseptic zones - Reduction of downtime and changeover times
Fast cleaning, ideal for frequent batch changes
Fewer dismantling steps and reduced personnel costs - Highly effective removal of complex residues
Powders, pastes, active ingredient deposits, oils, silicones, proteins and gels
Also cleans sealing areas, micropores, valves, delicate and small parts - Minimal moisture content
No risk of corrosion, therefore safe for electronic systems, sensors, actuators and medical device components
Fast recommissioning - Little to no chemicals
Higher workplace safety
Lower validation costs
No chemical contamination of product zones
- Validierbare, rückstandsfreie Reinigung
Keine chemischen Rückstände
Ideal zur Unterstützung von GMP- und FDA-Anforderungen
Reproduzierbare Ergebnisse für Audits & Dossiers - Hygienisch sichere Keimreduktion
Überhitzter Dampf reduziert Keime, Biofilme, Bakterien, Hefe & Schimmel
Besonders geeignet für Reinräume, Sterilbereiche und aseptische Zonen - Reduktion von Stillstand und Wechselzeiten
Schnelle Reinigung, ideal bei häufigen Batchwechseln
Weniger Demontage und geringerer Personalaufwand - Tiefenwirksame Entfernung komplexer Rückstände
Pulver, Pasten, Wirkstoffanhaftungen, Öle, Silikone, Proteine, Gele
Reinigt auch Dichtbereiche, Mikroporen, Ventile, Filigran- und Kleinteile - Minimaler Feuchtigkeitsanteil
Keine Korrosionsgefahr, somit sicher für Elektronik, Sensorik, Aktuatoren und medizintechnische Komponenten
Schnelle Wiederinbetriebnahme - Wenig bis keine Chemikalien
Höhere Arbeitssicherheit
Geringere Validierungskosten
Keine chemische Belastung der Produktzonen
Typical areas of application in pharmaceutical industry & medical technology
- Clean rooms (ISO 5–ISO 8)
- Manufacture of tablets, capsules & granules
- Aseptic bottling lines & isolators
- Mixers, agitators, containers, dosing and packaging systems
- Plants for the manufacture of ointments, gels and semi-solid forms
- Assembly of sensitive medical device components
- Cleaning of surgical instruments & production tools
- Conveyor technology, robot cells & validation areas
